Systems and methods for point of use evacuation of an array
Inventors
Wernerehl, Aaron • Jones, David E. • Zimmerman, Taylor • Ririe, Kirk M.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-12162005-B2
Publication Date
2024-12-10
Expiration Date
2038-05-23
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Abstract
Systems, methods, and apparatus are provided for evacuating and for filling an array at the point of use.
Core Innovation
The invention provides systems, methods, and apparatus for point-of-use evacuation and filling of an array, particularly in closed systems such as arrays of reaction wells or reagent blisters. The system includes an array assembly that can be evacuated on demand at the point of use, typically by applying a vacuum just before or during the execution of an analytical method. Unlike previous approaches where the vacuum is applied during manufacture and must be maintained through packaging and storage, the disclosed system allows an immediate, strong vacuum to be applied and used to draw fluid into the wells within seconds to minutes, minimizing residual air and bubble formation.
The system features an array assembly with a plurality of wells arranged in an array, a vacuum channel in fluid communication with the wells and a vacuum port, and an array fill channel between the wells and a fluid source. The fluid and vacuum channels can be co-aligned or even combined, and the apparatus can include openable seals such as frangible or peelable seals to prevent premature mixing or evacuation of the fluid reservoir. A piston pump or other vacuum device is used to evacuate the wells, and upon releasing the vacuum by opening the fill seal, fluid is drawn into each well efficiently and uniformly.
This invention addresses the problem of reliably filling analytical arrays, particularly in closed systems, without introducing bubbles, well-to-well variability, or contamination, as found in prior methods involving separate channels or positive pressure. By enabling in situ evacuation and filling without requiring vacuum storage or bulky, expensive packaging, it simplifies manufacturing, reduces cross-talk and contamination, and increases result consistency.
Claims Coverage
The patent includes two primary independent inventive features relating to the structure and function of an array assembly for point-of-use evacuation and filling, and to a reaction container implementing this assembly.
Array assembly with selectively openable vacuum and fill channels
The invention describes an array assembly that comprises: - A first and second film layer enclosing an array layer of a plurality of wells. - The first film layer bonds to one side of the array layer to seal a first end of each well, and the second film layer is bonded to the second side. - A vacuum channel is in fluid communication with the wells and a vacuum port, with the vacuum port as an opening in one or both film layers. The vacuum channel is selectively sealable to control vacuum access. - An array fill channel connects the wells to a fluid source, with a closed, selectively openable seal between the wells and fluid source. This inventive feature emphasizes the integrated channels for both vacuum evacuation and fluid filling, both being selectively controlled to facilitate in situ preparation and filling of the array assembly.
Reaction container incorporating the array assembly and fluidly connected chambers
The invention further covers a reaction container that includes: - The specified array assembly described above. - A plurality of fluidly connected reaction chambers in fluid communication with the array assembly. - An access opening in fluid communication with at least one of the reaction chambers. - A channel system (including the vacuum channel) providing paths such that each reaction well in the array is fluidly connected to the vacuum port by at least two paths and to the fluid source by at least two paths. This inventive feature encompasses the integration of the array assembly into a larger reaction container system with robust multi-path connections for increased reliability in fluid handling.
In summary, the inventive features define an array assembly for in situ vacuum evacuation and controlled fluid filling, and the incorporation of such an array assembly within a multi-chamber reaction container with multiplexed channel systems for enhanced analytical performance.
Stated Advantages
The system enables point-of-use evacuation and filling, eliminating the need for vacuum storage or expensive, vacuum-sealed packaging materials.
Applying the vacuum only at the point of use allows a near total vacuum to be achieved and utilized for consistent fluid filling, minimizing or eliminating air bubbles in the wells.
The architecture reduces the risk of cross-contamination or well-to-well variability by providing controlled, isolated fill and vacuum channels.
Manufacturing is simplified and costs are reduced since vacuum is not drawn through liquid and vacuum-sealed packaging is unnecessary.
Documented Applications
Nucleic acid analysis in closed systems, including arrays of reaction wells or reagent blisters for assays such as PCR.
Sample-to-answer testing devices for rapid, multi-target detection of infectious agents in clinical and environmental samples.
Automated instruments employing in situ evacuation and filling for analytical processes such as cell lysis, nucleic acid extraction, multiplex PCR, and sequential biochemical reactions.
Any system requiring reliable, bubble-free, contamination-free filling of arrays or PCR wells, particularly where point-of-use preparation is essential.
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